Medivation and Astellas announced that the FDA has approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel (Taxotere; Sanofi Aventis).

The efficacy and safety of Xtandi were assessed in a randomized, placebo-controlled, multicenter Phase 3 clinical trial. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either Xtandi orally at a dose of 160mg once daily (N=800) or placebo (N=399). The primary endpoint of the trial was overall survival. Xtandi-treated patients had a statistically-significant improvement in median overall survival compared to the placebo group: 18.4 months in the Xtandi group vs. 13.6 months in the placebo group (P<0.0001). Xtandi provided a 37% reduction in risk of death compared to placebo (hazard ratio=0.631).

Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Xtandi will be supplied as 40mg capsules. Medivation and Astellas expect to make Xtandi available in mid-September 2012.

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